SUPPLY CHAIN ARTICLES

• ARW's ATMP Manufacturing Must-Reads (ST. PATRICK'S DAY EDITION!)

  Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional roundup article.

• Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why

  The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.

• From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy

  In this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact. 

• 4 Risk Mitigation Strategies For mRNA Production

  Planning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.

• The RNA Therapeutics Supply Chain: A Platform of Relationships

  Conversations digging into RNA-specific sourcing considerations have been few and far between. Enter Sanofi's Greg Troiano. Together, we delved into the nuances, challenges, and opportunities for growth that currently exist within the mRNA drug substance and drug product (i.e., mRNA-LNP) raw material sourcing worlds.

• Therapeutic Oligonucleotides: Regulations & Quality Standards

  Oligonucleotides have surfaced in the past few years as promising therapeutic agents to treat diseases such as neurodegenerative disorders, respiratory disorders, cancer, and diabetic retinopathy. This article recaps a recent USP workshop where participants from regulatory agencies, industry, and academia gathered to discuss best practices and perspectives.